Director, Head of QA Compliance

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Director, Head of Compliance is responsible for providing leadership and managing all the quality systems for the day-to-day commercial operations. The incumbent will be responsible for implementing and executing the internal, customer audit and regulatory inspections program.  He/She must have a strong working knowledge of GMP requirements and ability to present and defend Lonza’s Quality Systems to existing and prospective customers, regulatory agencies and corporate compliance groups.

Key responsibilities:

• Manages all aspects of Compliance for a Phase III/Commercial GMP Viral Therapy/Cell Therapy  (VT/CT) contract manufacturing facility

• Develops and implements commercial quality systems for the facility including but not limited to Document Control and Recordkeeping, Deviation, Complaint  and CAPA systems, Change Control system, Internal and Customer Audit program, Regulatory inspection program, Risk Management program, validation, materials, document management.

• Ensures that Quality Systems for the VT/CT Manufacturing unit meet Lonza Global Quality Standards and applicable regulatory requirements.

• Manages and plans the work of the Quality Systems group.  Writes and/or reviews and approves Quality systems related SOPs.

• Participates in VT/CT related project teams as required.

• Meets with clients on a regular basis to ensure that QA systems meet their expectations.

• Leads, facilitates or participates in Regulatory Inspections and client audits.

• Selects, trains, and supervises staff to perform functions consistent with procedural and business requirements.  Develops, mentors, and coaches' direct reports as well as coaches other site personnel on Quality Systems use.

• Assesses implementation and use of site Quality systems on a regular basis and reports metrics to Site Quality Council with proposed actions if required.

• Leads continuous improvement efforts around the design and use of the site Quality Systems.

• Participates in cross-site forums and contributes to Lonza Pharma-Biotech (LPB) and Business Unit Quality policies and procedures as requested.

• Manages or performs other related duties as requested by manager.

• Manages Quality Systems and Compliance budget and resources to maximize efficiency and maintain quality/compliance at high levels.

• Perform other duties as assigned.

Key requirements:

• Bachelor’s Degree required in Life Sciences, Engineering or Quality Management; Master’s degree or equivalent experience Life Sciences, Engineering, or Quality Management

• 10+ years Extensive experience in establishing Pharmaceutical Quality Systems in a commercial cGMP environment, management of Quality teams, managing regulatory inspections including FDA

• Acts as a key communication link between operational layers and upper management

• Demonstrates timely and accurate decision making, ensuring delegation or escalation where appropriate

• Advanced experience managing quality issues related to biologics bulk drug substance and/or drug product manufacturing in a commercial environment.

• Excellent knowledge of global cGMPs related to all aspects of Biologics manufacturing, including ICH Q7 and FDA/EMA regulations related to cell/gene therapy and aseptic manufacturing of drug product.

• Certified Quality Auditor and experience in a CDMO setup a plus

• Ensures that teams support the execution of business strategy and/or specific objectives

• Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues.

• Routinely report on quality and compliance issues

• Anticipates and resolves challenges

• Provides coaching to enable/accelerate success outcomes

• Leads multiple complex initiatives simultaneously to successful conclusion

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.<